Effects of Physical Therapy on Isometric Neck Retraction Strength and Pain in Patients With Neck Disability

NCT04334655 | Completed

• 1 other identifier: CampbellU
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 4

Brief Summary

Impaired neck muscle strength is related to neck pain, abnormal posture, and various cervical pathologies. Clinicians, therefore require objective, reliable and valid methods for quantifying neck strength. In a previous study, the investigators developed a novel, valid, and reliable method for measuring neck retraction strength, using a handheld dynamometer (HHD), in normal, healthy individuals. The investigators are now expanding this research to study a patient population. Specifically, to describe isometric neck retraction strength in patients with neck pain and to study the effects of physical therapy (PT) on that strength. Our hypothesis is that isometric cervical retraction strength will increase over the course of treatment and that there will be an inverse relationship between strength and the Numeric Pain Rating Scale (NPRS) and Neck Disability Index (NDI).

Conditions

Neck Pain; Strength

Keywords

Neck Pain; Strength; Physical Therapy

Outcome Measures

Primary Outcomes (1)

• Change in Neck Retraction Strength

  Change in isometric Neck Retraction Strength measured with a Hoggan MicroFET2 hand-held dynamometer in kilograms at baseline, approximately every 30 days during the physical therapy intervention and immediately after the physical therapy intervention at discharge. The estimated period of time from baseline until completion is 3 months.

  At baseline (the initial evaluation) and every 30 days thereafter until discharge from PT. The estimated period of time from baseline until completion is 3 months.

Secondary Outcomes (2)

• Change in Neck Pain: Numeric Pain Rating Scale (NPRS)

  At baseline (the initial evaluation) and every 30 days thereafter until discharge from PT. The estimated time frame from baseline until completion is 3 months.

• Function

  At baseline (the initial evaluation) and every 30 days thereafter until discharge from PT. The estimated time frame from baseline until completion is 3 months.

Study Arms (4)

Clinic 1

Clinics will be identified using Clinic numbers: Clinic 1, Clinic 2, Clinic 3, Clinic 4. The interventions will be normal physical therapy interventions. The only addition is the monitoring of isometric neck retraction strength at the initial evaluation, progress reports, and discharge. The purpose of the study is not to administer new or specific interventions but to monitor neck strength changes over time during regular physical therapy care.

Other: Physical Therapy

Clinic 2

Clinics will be identified using Clinic numbers: Clinic 1, Clinic 2, Clinic 3, Clinic 4. The interventions will be normal physical therapy interventions. The only addition is the monitoring of isometric neck retraction strength at the initial evaluation, progress reports, and discharge. The purpose of the study is not to administer new or specific interventions but to monitor neck strength changes over time during regular physical therapy care.

Other: Physical Therapy

Clinic 3

Clinics will be identified using Clinic numbers: Clinic 1, Clinic 2, Clinic 3, Clinic 4. The interventions will be normal physical therapy interventions. The only addition is the monitoring of isometric neck retraction strength at the initial evaluation, progress reports, and discharge. The purpose of the study is not to administer new or specific interventions but to monitor neck strength changes over time during regular physical therapy care.

Other: Physical Therapy

Clinic 4

Clinics will be identified using Clinic numbers: Clinic 1, Clinic 2, Clinic 3, Clinic 4. The interventions will be normal physical therapy interventions. The only addition is the monitoring of isometric neck retraction strength at the initial evaluation, progress reports, and discharge. The purpose of the study is not to administer new or specific interventions but to monitor neck strength changes over time during regular physical therapy care.

Other: Physical Therapy

Interventions

Physical Therapy OTHER

Patients with primary complaints of neck pain will receive routine physical therapy care including modalities, manual therapy including neck mobilization and manipulation, stretching and strengthening exercises, and patient education.

Also known as: Rehabilitation, Neck Strengthening

Clinic 1; Clinic 2; Clinic 3; Clinic 4

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with neck pain receiving physical therapy

You may qualify if:

• \- 18 years of age or older Primary complaints of neck pain and receiving Physical Therapy

You may not qualify if:

• \- History of neck surgery Neurologic diseases Chronic Obstructive Pulmonary Disease (COPD)

Sponsors & Collaborators

• Campbell University, Incorporated: lead

Study Sites (4)

Integral Physical Therapy

Firestone, Colorado, 80504, United States

Location

Performance PT

Cos Cob, Connecticut, 06807, United States

Location

Connecticut Physical Therapy Specialists

Granby, Connecticut, 06035, United States

Location

Back in Action

Holly Springs, North Carolina, 27540, United States

Location

Related Publications (2)

• Tudini F, Myers B, Bohannon R. Reliability and validity of measurements of cervical retraction strength obtained with a hand-held dynamometer. J Man Manip Ther. 2019 Sep;27(4):222-228. doi: 10.1080/10669817.2019.1586167. Epub 2019 Mar 18.

  PMID: 30935321 RESULT

• Cagnie B, Cools A, De Loose V, Cambier D, Danneels L. Differences in isometric neck muscle strength between healthy controls and women with chronic neck pain: the use of a reliable measurement. Arch Phys Med Rehabil. 2007 Nov;88(11):1441-5. doi: 10.1016/j.apmr.2007.06.776.

  PMID: 17964885 RESULT

MeSH Terms

Conditions

Neck Pain

Interventions

Physical Therapy Modalities; Rehabilitation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Frank Tudini, DSc

  Campbell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: April 6, 2020
• Study Start: March 1, 2020
• Primary Completion: October 23, 2021
• Study Completion: October 23, 2021
• Last Updated: May 2, 2022

Record last verified: 2022-04

Locations

US (4)